1 Applying the Intricacies of the New Hypertension and Lipid Guidelines to Your Patients Joe Anderson, PharmD, PhC, BCPS James Nawarskas, PharmD, PhC, BCPS Gretchen Ray, PharmD, PhC, BCACP University of New Mexico College of Pharmacy OBJECTIVES • Discuss the current hypertension guidelines • Discuss the current lipid guidelines • Given a clinical scenario, utilize the new guidelines to recommend appropriate therapy
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1
Applying the Intricacies of
the New Hypertension and
Lipid Guidelines to Your Patients
Joe Anderson, PharmD, PhC, BCPS
James Nawarskas, PharmD, PhC, BCPS
Gretchen Ray, PharmD, PhC, BCACP
University of New Mexico College of Pharmacy
OBJECTIVES
•Discuss the current hypertension guidelines
•Discuss the current lipid guidelines
•Given a clinical scenario, utilize the new
guidelines to recommend appropriate therapy
2
Hypertension Guidelines
JOINT NATIONAL COMMITTEE (JNC)
• Federally funded program to produce hypertension guidelines
• Latest iteration was JNC 7 published in 2003
• NHLBI announced in June 2013 that it is withdrawing from guideline development, which would then be performed by “partner organizations”
• In August 2013, NHLBI established a “partnership” with AHA and ACC to develop hypertension, cholesterol, and obesity guidelines.
• While the cholesterol and obesity guidelines were released in November 2013, the hypertension guidelines were never developed.
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SO WHERE ARE OUR HYPERTENSION
GUIDELINES GOING TO COME FROM?
• JNC panel wasn’t comfortable with shopping guidelines around for endorsements, so they published their work (unendorsed) in JAMA on-line in December 2013 (JAMA 2014;311:507-520) as the document we now call JNC 8
• Once it became clear that AHA and ACC could not reach an agreement with the JNC panel, the former felt compelled to release some form of updated guideline for hypertension management, leading to an AHA-ACC Scientific Advisory Report released on-line November 15, 2013 (J Am Coll Cardiol 2014;63:1230-1238.)
This document is NOT a guideline, however, but more of a treatment algorithm which doesn’t really differ much from the 2003 JNC-7 recommendations
The AHA-ACC Task Force on Practice Guidelines intends to continue to work with NHLBI on producing hypertension guidelines with a goal of 2015 dissemination.
• Further complicating matters is the release of hypertension guidelines by the American Society of Hypertension & International Society of Hypertension in December 2013 (Available at: http://www.ash-us.org/documents/ASH_ISH-Guidelines_2013.pdf)
Bolded Statins and doses: RCTs demonstrating efficacy
Italicized statins and doses are FDA-approved but not tested in RCTs
*Individual responses to statin therapy varied in the RCTs. There might be a biologic basis for a less-than-
average response.
Stone NJ, et al. Circulation 2014;129[suppl 2]:S1-S45.
INTENSITY OF STATIN THERAPY
•Moderate intensity in place of high intensity for:
Multiple or serious comorbidities, including impaired renal or hepatic function
History of previous statin intolerance or muscle disorders
Unexplained ALT elevations > 3 x ULN
Concomitant use of drugs affecting metabolism
> 75 years of age
History of hemorrhagic stroke
Asian ancestry
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RISK ASSESSMENT FOR PRIMARY
PREVENTION: GROUPS 2, 3, AND 4
•Adults, aged 20 to 79 years
Reasonable to assess traditional ASCVD risk
factors (RF) every 4 to 6 years
- For adults aged 40 to 79 years, assess 10-
year ASCVD risk every 4 to 6 years
- Consider assessing 30-year or lifetime ASCVD
risk based on ASCVD RFs for adults 20 – 59
years
Goff DC, et al. Circulation 2014;129[suppl 2]:S49-S73.
RISK ASSESSMENT FOR PRIMARY
PREVENTION
• Obtain complete fasting* lipoprotein profile
total cholesterol, LDL, HDL, triglycerides
• Assess traditional ASCVD RFs
Current cigarette smoking
Hypertension (BP >140/90 mmHg or on BP
medication)
HDL-C <40 mg/dl
Age > 45 years in men or > 55 years in women
Diabetes (obtain hemoglobin A1c if status unknown)
• Calculate risk using Pooled Cohort Equations
• Discuss results with patient
* 9 to 12 hours without food or drink of any caloric value
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RISK ASSESSMENT FOR PRIMARY
PREVENTION
• Patient discussion
10-year risk and/or lifetime risk
Patient’s risk factors (including diet and exercise)
- Consider additional non-traditional RFs
• Family history (1st degree relative) of premature CHD (< 55 yrs in males, < 65 yrs in females)
• LDL-C > 160 mg/dL
• hs-CRP > 2 mg/L
• Coronary artery calcium score: > 300 agatson units or > 75th percentile for age, gender, & ethnicity
• Ankle-brachial Index (ABI): < 0.9
Importance of lifestyle changes
Review potential benefits and harms of statin therapy
Ask patient their treatment preferences
PATIENTS NOT IN STATIN BENEFIT
GROUPS
• No DM, between 40 and 75 years, 10-year risk 5 –7.5%
Lifestyle modification
Consider non-traditional RFs
+/- moderate intensity statin
• No DM, between 40 and 75 years, 10-year risk < 5%
Lifestyle modification
Consider non-traditional RFs
• No DM, < 40 or > 75 years
< 40, consider lifetime risk, non-traditional RFs
> 75, consider comorbidities, life expectancy, risks of therapy
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Cholesterol Treatment Trialists’ (CTT)
Collaborators
•Meta-analysis of 27
statin studies
•175,00 patients with
and without vascular
disease
•Relative risk per 1
mmol/L LDL-C
reduction based on
baseline 5-year CV
risk
Lancet 2012;380:581–90.
PATIENTS NOT IN STATIN BENEFIT
GROUPS
•DM, < 40 or > 75 years
Patient discussion
- Additional RFs
- Potential benefits vs adverse effects
- Patient preferences
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ADA STANDARDS OF MEDICAL CARE
2014
• Measure fasting lipid profile annually
• Statin treatment regardless of lipid levels for diabetic patients with:
Overt CVD: secondary prevention
Primary prevention if age > 40 yrs with > 1 CV RF (Fam Hx, HTN, smoking, dyslipidemia, albuminuria)
• Primary prevention goal: LDL < 100 mg/dL
Optional secondary prevention goal: LDL < 70 mg/dL with a high dose statin
• If drug-treated patients do not reach the above goals on maximum tolerated statin therapy, a reduction in LDL of 30–40% from baseline is an alternative goal.
• Combination therapy above statin therapy not shown to be beneficial and is not recommended
Diabetes Care 2014;37:S5-S13
STATIN SAFETY
•Creatine kinase (CK)
Baseline CK is reasonable if at increased risk of myopathy
CK should not be routinely measured
Reasonable to measure CK in patients with muscle symptoms
If suspecting rhabdomyolysis, measure CK, creatinine, urinalysis for myoglobinuria
•Liver function tests (LFT), specifically ALT
Baseline ALT before initiating statin therapy
Reasonable to measure ALT in patients with symptoms suggestive of hepatotoxicity
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STATIN SAFETY
•New onset diabetes
Depends on statin intensity
Stone NJ, et al. Circulation 2014;129[suppl 2]:S1-S45.